510(k) K190978 ยท IYE Accelerator, Linear, Medical
RefleXion Medical Radiotherapy System
| Applicant | Reflexion Medical, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Mar 12, 2020 |
| Received | Apr 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2021 | Reflexion Medical, Inc. RefleXion Medical Radiotherapy System -
System Label: "*** refleXion REF RXM1000 ***"
Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.